Dento-skeletal Effects of Quadhelix Versus Mini-hyrax Expanders in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Randomized Clinical Trial (RCT)

March 5, 2026 updated by: Mahmoud Sherif, Cairo University

Regarding expansion in cleft lip and palate patients, very few clinical trials were found after searching literature and fewer randomized trials. This means that no enough evidence in literature is tackling expansion in cleft lip and palate patients.

To the best of our knowledge, this study will represent the first RCT to compare the dentoskeletal effects of mini-hyrax vs quadhelix. Since cleft cases usually need greater anterior than posterior expansion, both appliances are capable of anterior expansion. Nevertheless, no other study compared how much anterior expansion could be accomplished by either appliance.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Maxillary expansion is usually performed before the secondary alveolar bone grafting procedure. Expansion improves the maxillary arch morphology and causes the segmental alignment creating appropriate conditions for bone grafting surgery as well as correcting the posterior crossbites. An important treatment objective in cleft cases is to achieve greater anterior than posterior maxillary expansion since there is a greater anterior than posterior maxillary constriction in most of those patients. Variable appliances have been used for maxillary arch expansion in cleft patients.

  • Hyrax expanders exert parallel forces to the alveolar bones and the maxillary complex, generating similar amounts of anterior as well as posterior expansion and might be indicated for patients with overall maxillary transverse deficiency. While with patients of greater anterior constriction, Hyrax expander must be frequently interrupted before the full correction of the anterior transverse deficiency in order to avoid the occurrence of a posterior buccal crossbite.
  • Fan-shape expanders and mini-hyrax (supported on the first premolars and associated to a transpalatal arch cemented to the first molars) enhanced expansion in the maxillary anterior region and restricted posterior expansion.
  • Mini-hyrax (supported on the first permanent molars) can expand anteriorly as well as posteriorly and was found comparable to hyrax.

I this study we are comparing the dentoskeletal effects of quadhelix versus mini-hyrax utilizing CBCT and digital models performed before and after expansion.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Manial
      • Giza, Manial, Egypt, 11553
        • Faculty of Dentistry Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Mixed dentition.
  2. Both males and females.
  3. Unilateral cleft lip and palate
  4. Presence of maxillary constriction that needs maxillary expansion prior to secondary alveolar bone grafting.
  5. Erupted first permanent maxillary molars.
  6. Good periodontal health.
  7. No previous orthodontic treatment

Exclusion Criteria:

  1. Syndromic cleft lip and palate patients.
  2. Previous secondary alveolar bone grafting.
  3. Taking medications that influence growth.
  4. Absence of teeth to support the expansion appliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Quadhelix Group
CLP pts with quadhelix expander
Device: Quadhelix Expander
Maxillary Expander
Active Comparator: Minihyrax Group
CLP pts with minihyrax expander
Device: Minihyrax Expander
Maxillary Expander

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior transverse dento-skeletal effects measured by linear distance tool between deciduous upper canines on CBCT and digital models (axial view)
Time Frame: 6 months
Digital models and CBCTs are used to compare dentoskeletal effects before and after expansion
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maxillary and mandibular anteroposterior measurements measured by linear distance tool and angle measurement tool on CBCT and digital models (sagittal view)
Time Frame: 6 months
Digital models & CBCT
6 months
Vertical skeletal measurements measured by angle measurement tool (y-axis angle - SnMp) on CBCT (sagittal view)
Time Frame: 6 months
CBCT
6 months
Dentoskeletal Effects measured by angle measurement tool on CBCT (Coronal view)
Time Frame: 6 months
Molar inclination
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Figueiredo DSF, Bartolomeo FUC, Romualdo CR, et al. Dentoskeletal effects of 3 maxillary expanders in patients with clefts: A cone-beam computed tomography study. Am. J. Orthod. Dentofac. Orthop. 2014;146(1):73-81.
  • Pugliese, Fernando et al. "Dental arch size and shape after maxillary expansion in bilateral complete cleft palate: A comparison of three expander designs." The Angle orthodontist vol. 90,2 (2020): 233-238.
  • Oliveira, Dauro Douglas et al. "An alternative clinical approach to achieve greater anterior than posterior maxillary expansion in cleft lip and palate patients." The Journal of craniofacial surgery vol. 25,6 (2014): e523-6.
  • Figueiredo, Daniel Santos Fonseca et al. "Effects of rapid maxillary expansion in cleft patients resulting from the use of two different expanders." Dental press journal of orthodontics vol. 21,6 (2016): 82-90.
  • IPDTOC Working Group. Prevalence at birth of cleft lip with or without cleft palate: data from the International Perinatal Database of Typical Oral Clefts (IPDTOC). Cleft Palate Craniofac J 2011;48:66-81.
  • Mossey PA, Shaw WC, Munger RG, Murray JC, Murthy J, Little J. Global oral health inequalities: challenges in the prevention and management of orofacial clefts and potential solutions. Adv Dent Res 2011;23:247-58.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

February 28, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 27-05-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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